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Идёт набор NCT07048236

Specimen and Clinical Data Collection Plan for LDCT Screening Participants

— Наблюдательное Lung Cancer Smoking Family Relations

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Specimen and clinical data collection.
Кому может быть актуально
Состояния в реестре: Lung Cancer, Smoking, Family Relations. Базовые параметры: 20 лет — 74 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Тайвань
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

Lung cancer remains the leading cause of cancer-related mortality in Taiwan and globally, with increasing incidence and the highest healthcare cost burden among cancers in Taiwan. Despite the widespread use of low-dose computed tomography (LDCT) for screening smokers, over half of lung cancer cases in Taiwan occur in never-smokers, highlighting the need for improved risk stratification. Current national LDCT screening programs do not collect comprehensive risk-related data, limiting their predictive accuracy. This project proposes a five-year, multi-center initiative to establish an integrated biospecimen and clinical data collection system. In its first year, a feasibility pilot will be conducted, followed by recruitment of 12,000 participants. Data collection will include biospecimens (blood, urine, tissue), genomic and proteomic analyses, imaging, and detailed questionnaires covering lifestyle, environmental, and occupational exposures. The project will also develop and validate lung cancer prediction models incorporating epidemiologic, biomarker, air pollution, and imaging data. A Common Data Model (CDM) will be implemented to ensure cross-institutional data standardization and support future international collaboration.

Вмешательства

  • Диагностический тест Specimen and clinical data collection
    Check total bilirubin, urinary heavy metals,CRP, serum tumor marker, pulmonary function test,Questionnaire

Первичные конечные точки

  • Definitive diagnosis of lung lesions confirmed by histopathological or cytological examination. [Срок оценки: Measured from time of suspicious imaging finding to histopathological or cytological diagnosis, within a 12 years period]

Критерии участия

Критерии включения

Previous heavy smokers

According to The Lung Cancer Early Detection Program in Taiwan:

Adults aged 50 to 74 years with a smoking history of at least 20 pack-years, who are either current smokers or have quit smoking within the past 15 years. Current smokers must agree to participate in a smoking cessation program.

First-degree relatives of lung cancer patients

According to The Lung Cancer Early Detection Program in Taiwan:

Men aged 45 to 74 years and women aged 40 to 74 years who have a biological parent, child, or sibling diagnosed with lung cancer. Individuals who currently smoke must agree to participate in a smoking cessation program.

Критерии исключения

  • Pregnancy
  • History of chest computed tomography (including low-dose CT) within the past 12 months.
  • Previous diagnosis of lung cancer
  • Inability to undergo thoracic biopsy or surgery
  • Inability to complete the scan procedure, such as due to being unable to hold their breath.
  • Unexplained hemoptysis within the past month
  • Chest X-ray within the past month showing a clearly suspicious lung lesion
  • Unexplained weight loss exceeding 6 kilograms within the past year

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Тайвань · 2 центра
  • Chung Shan Medical University — Taichung
  • Ministry of Health and Welfare Shuang-Ho Hospital — New Taipei City

Идентификаторы

NCT: NCT07048236 · CS1-25029

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗